RUSCH IPN044685Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026704547616), received between May 18, 2021 and Jun 30, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

35 other recalls cover devices cleared under the same FDA submission (K961837); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 25, 2023Open, Classified

   Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

   Z-1849-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Gas/Air Leak

  IT WAS REPORTED THAT "THE CUFF AND THE PILOT BALLOON SEEM TO BE TRANSFERRING THE AIR BETWEEN EACH OTHER. THE PILOT BALLOON DOESN'T RETAIN ANY AIR, AND ETT CUFF STARTED TO DEFLATE WHILE IN PATIENT. CUSTOMER WENT A DIFFERENT DIRECTION TO COMPLETE THE PROCEDURE." NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669503 ↗
• MalfunctionMar 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "END USER INDICATED KINKING IN ETT. PHYSICIAN INDICATED THERE ARE NO PATIENT HEALTH ISSUES CONNECTED TO THE COMPLAINTS. PRODUCT WAS PRE-INFLATED FOR TESTING. RE-INTUBATION AND ANY DESATURATION OF 02 ARE NOTED IN CASE EVENTS."

  Patient problems: Low Oxygen Saturation

  MAUDE report 21661421 ↗
• MalfunctionJan 30, 2023Leak/Splash; Leak/Splash

  REPORTED EVENT: ENDOTRACHEAL TUBE CUFF LEAKED AND REQUIRED TUBE TO BE REPLACED. NO REPORTED INJURY. MEDWATCH REPORT#: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 16265435 ↗
• MalfunctionMay 18, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "[ON] (B)(6) 2021 5:19PM PT INTUBATED IN THE OR WITH 7.0 TELEFLEX ETT. IN ICU - (B)(6) AM PT HAD PEAK VENTILATOR PRESSURES OF 10 - 11 CM H20 THEN THEY BEGAN READING 34-38 CM H2O, PATIENT WAS AGITATED AND HAD DIFFICULTY PASSING A SUCTION CATHETER. (B)(6) 12:29PM REMOVED THE ETT AND REINTUBATED, VENTILATOR PEAK PRESSURES RETURNED TO BASELINE OF 10-11 CM H20". PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Airway Obstruction

  MAUDE report 11843248 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961837. One submission often covers many models, so check the product and lot details in each record.

• Z-1846-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555
• Z-1853-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
• Z-1883-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
• Z-1891-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085
• Z-1889-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
• Z-1851-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
• Z-1962-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
• Z-1899-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
• Z-1886-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060
• Z-1881-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
• Z-1960-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
• Z-1885-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055
• Z-1963-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
• Z-1847-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
• Z-1852-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585

…and 20 more.